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Magnesium Sulfate (MgSO4)

Product Profile

>> Read the full case study (PDF)

Problem and Proposed Intervention


The second leading cause of maternal death is pre-eclampsia/eclampsia—most often detected through the  elevation of blood pressure during pregnancy—which can lead to seizures, kidney and liver damage, and both maternal and infant deaths, if untreated. These conditions claim the lives of an estimated 63,000 women each year, as well as the lives of many of their babies.1 Where a woman gives birth should not decide her fate, and yet the risk that a woman in a developing country will die of pre-eclampsia/eclampsia is approximately 300 times higher than that for a woman in a developed country.1  Several studies have identified magnesium sulfate (MgSO4) as the most effective anticonvulsant for preventing and treating the life-threatening seizures of eclampsia.  MgSO4 is needed at every level of the health care system where deliveries occur, from urban hospitals to rural clinics.2  Most of women with pre-eclampsia will also require antihypertensive therapy, even while on MgSO4.10 Supportive policies and appropriate practices are required to take this important medicine to scale to help reach the Millennium Development Goal (MDG) 5 target: reducing maternal mortality by 75% by 2015.

Magnesium Sulfate (MgSO4) product characteristics:

Drug/Product:

Magnesium Sulfate (MgSO4)

Selected Indication:

Prevention and treatment of eclampsia.

Formulation:

Injection 500 mg/ml in a 2-ml ampoule (50% solution), 500 mg/ml in a 10-ml ampoule (20% solution).3  Note: MgSO4 is also widely available in other formulations.

Dose:

Loading dose: Slow IV injection of 4g (20mL of 20% solution in saline) at a rate of 1g/5 minutes over 5-20 minutes.

Maintenance regime (Intramuscular (IM)): 10g of 50% solution; with 5g of 50% solution every 4 hours for 24 hours following last convulsion.

Maintenance regime (IV): 1 to 2g/ hour in 100mL of maintenance solution. 

Avg. Cost:

Approximately US$0.10 per ml (supplier median price)4 or approximately US$1.00 per dose.



Read more below.



Initial Findings from Product Case Study Working Paper

 

* Note: The strengths and challenges outlined below are initial findings from a longer working paper developed to analyze the current global situation of each product.  The findings are presented below to catalyze further thinking and discussion in order to finalize a list of issues and recommendations. The full working paper texts are forthcoming.

 

 

 

Strengths

Challenges

Policy and Regulation

 

 

Global

* MgSO4 is recognized by the WHO as the safest, most effective, and lowest-cost medication for preventing and treating eclampsia.

* Included on the WHO EML[1] “for use in eclampsia and severe pre‐eclampsia...”3

*Questions on how best to use MgSO4 for women with severe pre-eclampsia/eclampsia still pending, including the minimum effective dose, advantages and disadvantages of intramuscular and IV administration, the sufficiency of the loading dose alone, and the best time to stop treatment.4

National, Regional

* Case studies show MgSO4 was included in national protocols for maternal health service provision, in the Essential Medicine Lists, and in standard treatment guidelines in the majority of countries reviewed.

* Most countries have MgSO4 on their Essential Medicine Lists.5

* In a survey of 31 countries, MgSO4 is registered in all countries.5

* While national treatment policies to support the use of essential medicines such as MgSO4 exist, these policies are not always implemented in routine service delivery. 

* Multiple source documents show that some national standard treatment guidelines limit which health providers are authorized to administer MgSO4, and limit its use to specialized care facilities.  Task-shifting occurs, nonetheless, such that untrained staff may be using the product in less than adequate facilities.

* Programs for the prevention and management of pre-eclampsia and eclampsia are not as well developed as postpartum hemorrhage programs.

Product specification & characteristics

 

* Some countries have a large variety of formulations available that are not in-line with WHO recommendations (see product characteristics above).National procurement should focus on a standard formulation to avoid confusion within a given health care facility.  MgSO4, for example, is available in 20% and 15% formulations in some countries, while the WHO recommendation is 50%.6 This requires providers to calculate the difference and adjust the dosage accordingly. 6

Financing, Procurement & Supply

* Produced by one global manufacturer and many local manufacturers worldwide.4

* Eligible for the WHO Prequalification of Medicines Program.  To date no manufacturers’ medicine has qualified under this program.

 

* A group of international experts found that there are few incentives for pharmaceutical manufacturers to produce MgSO4, a low cost and low volume product.1

* Although MgSO4 is endorsed in all national policies  in a survey of 31 countries, only 48% of countries reported MgSO4 as consistently available in facilities.5

* Unregistered and unapproved medicines are often widely available, especially in the private sector, and many regulatory authorities are unable to restrict their availability. Surveys have found countries with unregistered medicines or brands of MgSO4 with an unknown origin and quality at the user level.7

* Broader recurring supply chain issues result from lack of policy enforcement; weak regulatory capacity; lack of adequate monitoring and supervision; lack of reliable quantification of needs; inadequate procurement planning; poorly designed or implemented logistics management information systems; weak infrastructure with low staffing at the district and facility level; and a limited pool of skilled human resources at all levels of the health system.

* The source of funding available for MgSO4 in many countries is unclear or unknown – an area that would benefit from greater study.

Service Provision (Rational Use)

 

* Country studies find a consistent gap between policy and practice.  Many providers are not familiar with the treatment options and guidelines for pre-eclampsia and eclampsia using MgSO4, and MgSO4 is often not used by providers because of lack of knowledge and skill in administration.8,9 There is also a lack of knowledge of clinical protocols with respect to timing and dosing.8

*In some locations, providers rely on diazepam, a less effective medication with more adverse neonatal effects, but one that they are familiar with and that is relatively easy to use in rural facilities.

* Studies have found that some providers do not use MgSO4 out of concern for side effects, safety and utility.9

* Because initial treatment for pre-eclampsia and eclampsia takes place at health centers before the patient is transferred to higher level facilities for ongoing care, the second dose of MgSO4 may be missed, due to poorly functioning referral systems.



Coming soon: Read the full case study (PDF).


[1] EngenderHealth. Balancing the Scales: Expanding Treatment for Pregnant Women with Life-Threatening Hypertensive Conditions in Developing Countries; A Report on Barriers and Solutions to Treat Pre-eclampsia & Eclampsia. Engender Health; 2007.  http://www.engenderhealth.org/ files/pubs/maternal-health/EngenderHealth-Eclampsia-Report. pdf. Last accessed March 23, 2012.

[2]  USAID, JHPIEGO.  Rapid Landscape Analysis of technologies for postpartum hemorrhage. Conducted by JHPIEGO/Accelovate for USAID at the Technologies for Health Consultative Meeting - MNCH Pathways. Unpublished. 2012.

[3] WHO. WHO Model List of Essential Medicines (March 2011), 17th edition.  Available at:  http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf.  Accessed March 26,2011

[4] USAID, PATH. Rapid Landscape Analysis of Technologies for Preeclampsia/Eclampsia. Presented at: Technologies for Health Consultative Meeting—MNCH Pathways, February 15, 2012; Washington, DC.

[5]  Fujioka A, Smith J. Prevention and Management of Postpartum Hemorrhage and Pre-Eclampsia/Eclampsia: National Programs in Selected USAID Program-Supported Countries. Maternal and Child Health Integrated Program (MCHIP); 2011. Available at: http://www.k4health.org/system/files/PPH_PEE%20Program%20Status%20Report.pdf. Accessed February 2012.

[6]  UNFPA, Lao PDR Ministry of Health. Review of Current Status in Access to a Core Set of Critical, Life-saving Medicines for Maternal/Reproductive Health in Lao PDR: Mission Report. UNFPA and Lao PDR Ministry of Health; 2008.

[7] United Nations Population Fund (UNFPA), WHO. Joint UNFPA/WHO Mission in Collaboration with the Ministry of Health to Review the Current Status of Access to a Core Set of Critical, Life-saving Maternal/Reproductive Health Medicines in Mongolia. 2009. Available at: http://digicollection.org/hss/documents/s16325e/s16325e.pdf. Accessed February 2012.

[8]  MSH. Active Management of the Third Stage of Labor in Health Care Facilities: Results of a National Study in Ghana, 2007. Arlington, VA: MSH, Prevention of Postpartum Hemorrhage Initiative; 2008.

[9]  Barua A, Shuchita M, Bracken H, Easterling T, Winikoff B. Facility and personnel factors influencing magnesium sulfate use for eclampsia and pre-eclampsia in 3 Indian hospitals. The International Journal of Gynecology & Obstetrics. 2011; 115(2):231–234.

[10] Duley L, Farrell B, Spark P, Roberts B, Watkins K, Bricker L, et al. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet 2002;359:1877-90